Skip to main content
OpenTrials
Completed

NCT Number: NCT02567955

Immunogenicity and Safety of Gardasil-9 and Cervarix

A ninevalent HPV vaccine (Gardasil-9) has been recently approved for clinical use. No data on immunogenicity and safety of interchangeable use of the ninevalent and the bivalent vaccine (Cervarix) are available. The main objective of this study is to assess the immunogenicity of ninevalent and bivalent HPV vaccines when administered to 9-10-year-old girls and boys according to 0-6 month schedule.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HPV Vaccines Immunogenicity and Safety

Age range

9 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Équipe de recherche en vaccination

Québec, G1E7G9, Canada

About this study

The proportion of subjects with detectable antibodies and antibody geometrical mean titers to 9 HPV genotypes included in the Gardasil-9 vaccine will be assessed 1 and 6 months post-first dose and 1, 18 and 36 months post-second dose of vaccine.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 9-10-year-old girls and boys

Exclusion criteria

  • previously received an HPV vaccine
  • immunosuppressed
  • known allergy to a vaccine component

Treatment and study plan

Immunogenicity two doses of Gardasil-9

Biological

Subjects will receive two standard doses of Gardasil-9 (0.5 ml)

Other names: HPV vaccine

Immunogenicity Cervarix and Gardasil-9

Biological

Subjects will receive a standard dose of Cervarix (0.5 ml) and a standard dose of Gardasil-9 (0.5 ml)

Other names: HPV vaccine

Primary outcomes

  1. Comparison of proportion of subjects with detectable antibodies to 9 HPV genotypes included in the Gardasil-9 vaccine observed in two study arms

    Time frame: 36 months post-second dose of vaccine

    A Luminex Total IgG assay will be used to assess the presence of antibodies and antibody titers to 9 HPV genotypes included in the Gardasil-9 vaccine. Luminex Units will be used for the antibody titers assessment.

Secondary outcomes

  1. Comparison of tolerability profile of Gardasil-9 and Cervarix

    Time frame: During 5 days after each vaccine dose administration.

    Local and general symptoms observed after each vaccine dose will be assessed by using a standardized diary card. Proportion of subjects who reported local and/or general symptoms will be compared.

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Official study title

Immunogenicity and Safety of Gardasil-9 and Cervarix When Administered to 9-10-year-old Subjects According to 0-6 Month Schedule

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Oct 5, 2015
Registry last updated
Jan 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.